Having secured deals with AstraZeneca and Novartis, Niowave is constructing a second facility to meet rising demand for actinium-225, which can be used to develop next-generation radiopharmaceuticals.
Niowave has started building a $75 million facility in Lansing, Michigan, to increase its capacity to make a radioisotope.
The company already operates a site in Lansing. Adding a second dedicated production facility at the site will increase Niowave’s capacity to support growing global demand for actinium-225 and other medical isotopes. The company expanded its agreement to deliver actinium-225 to AstraZeneca in December and struck a deal to supply actinium-225 to Novartis in February.
Niowave is installing multiple proprietary superconducting linear accelerators at its latest actinium-225 plant, which will also house processing and quality systems. The facility is scheduled to start operations in 2028 and create about 70 jobs in R&D, engineering and quality assurance.
The construction project is part of a broader effort boost actinium-225 production. Historically, Oak Ridge National Laboratory met demand for actinium-225 by making the radioisotope through the decay of thorium-229 left over from nuclear programs in the 1940s and 1950s. However, rising investment in actinium-225 drug development has necessitated the addition of new sources of the radioisotope.
In recent years, companies such as AstraZeneca, Bristol Myers Squibb and Eli Lilly have invested in drug candidates based on the alpha-emitting radioisotope actinium-225. The choice of isotope differentiates the candidates from approved products such as Novartis’ Lutathera and Pluvicto, which deliver the beta emitter lutetium-177.
Compared to lutetium-177, actinium-225 emits more energy over a smaller area. The differences extend to the supply chain, with the nuclear research reactor used to generate lutetium-177 unable to produce actinium-225. Shortages of actinium-225 drove BMS’ RayzeBio to pause a Phase 3 trial in 2024, Endpoints News reported.
Since then, companies have invested in adding production capacity for the radioisotope. In the past two months alone, Cardinal Health has reported a significant expansion of its actinium-225 production capabilities at a site in Indianapolis, and TerraPower Isotopes has broken ground on a $450 million plant in Philadelphia that will make the radioisotope.
Niowave’s deals with AstraZeneca and Novartis are part of a series of agreements that drug developers have formed in recent years to secure supplies of actinium-225. Bayer agreed to source the isotope from BWXT, Ionetix, NorthStar Medical Radioisotopes and PanTera between 2022 and 2024. Lilly invested in actinium-225 manufacturer Ionetix in 2024.
